Health min issues regulatory pathways for foreign produced COVID-19 vaccines

Fast track approval to facilitate quick access to imported vaccines and optimal utilisation of domestic manufacturing facilities

Following the Union Government’s approval of April 13 to streamline and fast track the approval of COVID-19 vaccines approved for restricted use by overseas regulators like the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), the government today released specific regulatory pathways for these vaccines.

It is hoped that these decisions will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country, as per the health ministry release.

As per health ministry data, the four days of Tika Utsav saw intense vaccination activity. 29,33,418 vaccination doses were given on 11th April, another 40,04,521 were administered the next day. The corresponding figure for 13th and 14th April stands at 26,46,528 and 33,13,848. The total vaccination figures during the Tika Utsav saw a jump of 1,28,98,314 vaccine doses being administered to people of the eligible groups across the country. Three States have administered more than 1 crore vaccinations cumulatively. These are Maharashtra (1,11,19,018), Rajasthan (1,02,15,471) and Uttar Pradesh (1,00,17,650).

The Central Drugs Standards Control Organisation (CDSCO) headed by DCGI has today explained that the following would be the Pathway:

CDSCO shall prepare detailed guidelines specifying regulatory pathway for approval of foreign approved COVID vaccines based on NEGVAC recommendations.

These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders.

Applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO.

Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India (in case it does not have an Indian subsidiary).

CDSCO will process such applications for Restricted Use in Emergency Situation and DCGI will consider and take a decision within 03 working days from date of submission of complete application by the applicant.

DCGI will issue permission for Restricted Use in Emergency situation with, inter-alia, the following conditions:

Vaccine shall be used as per the guidelines prescribed under National COVID-19 Vaccination Programme.

First 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further Vaccination program.

Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.
Applications for Restricted Use in Emergency situation for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and application for import license.

CDSCO will process applications for Registration Certificate (registration of oversees manufacturing site and product: in this case COVID vaccine) and Import License, within three working days from the date of approval of Restricted Use in Emergency Situation.

As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory (CDL), Kasauli before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme.

The applicant will use COVID vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.

CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.

CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within seven days of the receipt of the proposal.

Applicant will conduct the bridging trial within the time lines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO.

After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in Emergency situation.